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The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner manufacture are supported by a proprietary software system. The clinician receives the aligners and provides them in sequential "stages" to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligners are held in place by presure and can be removed by the patient at any time. Several treatment options may be integrated into the Spark Clear Aligners, such as cutouts, hooks, and/or other attachment shapes, bite ramps, etc. to aid the aligners with teeth movement. The integrated occlusion guides on the upper and lower aligners allow the option of incrementally repositioning the mandible (lower jaw) forward to address in patients who have not reached full skeletal maturity.

This document is a 510(k) clearance letter for the Spark™ Clear Aligner System. It describes the device, its intended indications for use, and confirms its substantial equivalence to previously cleared devices. However, it does NOT contain the detailed information necessary to answer your questions about acceptance criteria and the study proving the device meets those criteria.

Typically, such information, especially related to the performance of a device against specific acceptance criteria and the methodologies of studies (like sample sizes, expert qualifications, ground truth establishment, etc.), would be found in detailed performance study reports or summaries submitted as part of the 510(k) application, but this clearance letter does not include that level of detail.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance and substantial equivalence, not the specifics of performance testing or clinical study design.

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Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement without etching.

Ormco™ EtchFree Adhesive is a light-curing adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.

The Ormco™ Bonding System consists of a primer, a sealant, an adhesive, and bonding accessories.

· Ormco™ Bonding Primer is intended to bond orthodontic appliances such as metal brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement. The primer is a clear liquid that conditions the surface of the application of a bonding sealant/enhancer. Ormco Bonding Primer is designed to be used as a system along with Ortho Solo and Ormco" Bonding Adhesive. The primer is offered in single-use vials which will be sold in kits and separately.

· Ormco™ Adhesive is a light-curing composite that is intended to be used with metal and ceramic brackets for orthodontic treatment and can also be used as aligner attachment. It is a convenient off-white paste providing aesthetics when used as aligner attachments or beneath a bracket. The adhesive is designed to be used as a system along with Ormco Bonding Primer and Ortho Solo. The adhesive is offered in syringes for multi-patient use, which will be sold in kits and separately.

This document describes the Ormco™ EtchFree Bonding System, comprising the Ormco™ EtchFree Bonding Primer and Ormco™ EtchFree Adhesive, and its substantial equivalence to predicate devices. The information provided focuses on non-clinical performance bench testing rather than clinical studies related to human reader performance or detailed AI-specific metrics.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. It lists the international and FDA-recognized consensus standards against which non-clinical performance bench testing was conducted. It generally states that "All results were deemed acceptable."

However, based on the mentioned tests, we can infer the areas of performance evaluated:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical performance bench testing. It does not mention clinical studies or human test sets. Therefore, details regarding sample size for test sets, country of origin, or retrospective/prospective data are not applicable in this context. The "test set" refers to materials or samples used in laboratory bench tests. The specific number of samples for each bench test (e.g., how many specimens for shear bond strength) is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical bench testing of a dental adhesive system. There is no mention of experts or ground truth establishment in the context of human assessment or interpretation of results for a test set. The "ground truth" for these tests would be the measurement results against established scientific standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no mention of a human-centric test set requiring adjudication in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device described is a dental adhesive system, not an AI-powered diagnostic tool or image analysis system. There is no mention of AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical dental product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench tests, the ground truth is established by the scientific and engineering principles and methodologies outlined in the referenced international and FDA-recognized consensus standards (e.g., ISO 29022 for shear bond strength, ISO 11405 for adhesion, ISO 10993 series for biocompatibility). The "truth" is whether the material properties or biological responses meet the specifications or thresholds defined by these validated tests.

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI model or algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above (physical product, not AI).

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The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear, plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner design, and aligner manufacture are supported by a proprietary software system. The clinician receives the aligners and provides them in sequential "stages" to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The aligners are held in place by pressure and can be removed by the patient at any time. The aligners are individually identified and dispensed to patients and are to be worn in a specific prescribed sequence. Several treatment options may be integrated into the Spark Clear Aligners consisting of:

• Attachments: Attachments are small protuberances of tooth-colored dental bonding material and may be prescribed by the dental clinician to act as anchor points on the teeth to focus the forces of the aligner to help with teeth movement.

o Templates: Attachments are placed onto the teeth via Templates. The dental practitioner may choose a standard dental composite, to fill into the Template themselves, and adhesive to bond the attachments onto the dentition. The option for composite material to be prefilled into the Template during manufacturing is also available via Prefilled Attachment (PFA) Templates.

• Hooks & Cutouts: Hooks and Cutouts may be designed into the aligner to accommodate elastics for aiding in applying additional aligner forces. Integrated Hooks are an optional alternative to the traditional Hooks.

• Bite ramps: Bite ramps are step features built into the lingual surfaces of the upper and lower aligner arch that are used by the clinician to prop open the bite temporarily so that certain teeth have a clearer path for movement without interference.

• Pontics: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment.

· Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.

The provided text is a 510(k) summary for the Spark™ Clear Aligner System. It describes the device and its intended use, and compares it to a legally marketed predicate device to establish substantial equivalence. However, this document does not contain the specific details about acceptance criteria, device performance, or a study designed to prove the device meets those criteria, as typically found in a clinical or performance study report.

The document states: "Non-Clinical performance bench testing to international standards and FDA recognized consensus standards for Aligner, Sequential Device has been conducted to determine conformance" and lists several ISO and ASTM standards. It also mentions biocompatibility testing. Crucially, it states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text explicitly states that clinical testing was not conducted, and it does not detail the specific performance results or acceptance criteria from the non-clinical bench testing.

Here's a breakdown of why each specific point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document mentions conformance to international standards (e.g., ASTM F 1980-21, ISO 14971, ISO 10993 series, ISO 7405, ANSI ADA Standard No. 41-2020) for non-clinical bench testing and biocompatibility. However, it does not detail specific acceptance criteria (e.g., a certain tensile strength or alignment accuracy) or quantify the device's performance against those criteria.
2. Sample size used for the test set and the data provenance: Not mentioned. Since no clinical testing was conducted and the details of non-clinical bench testing are not provided beyond listing standards, the sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set are not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Ground truth is typically established in clinical studies or human-in-the-loop evaluations, which were explicitly stated as not being conducted.
4. Adjudication method for the test set: Not mentioned. Adjudication is relevant for expert-based ground truth establishment, which did not occur according to the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and not mentioned. MRMC studies are typically for diagnostic AI systems involving human readers interpreting images, which is not the nature of this physical aligner system. The device is a physical orthodontic appliance, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical appliance, not a standalone algorithm in the typical sense of AI and software. While it has proprietary software for treatment planning, the document does not discuss its standalone performance in a quantifiable manner against specific criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. As clinical testing was not performed by the applicant (for this submission), there's no ground truth established in that context. The "ground truth" for the non-clinical testing would refer to the validated methods and metrics within the specified international standards, but specific details are not provided.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model that undergoes "training" the way machine learning models do. While its proprietary software might use data, the document does not describe it in terms of AI model training.
9. How the ground truth for the training set was established: Not applicable, for the same reasons as point 8.

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SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

SparkTM Software System: The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

The Ormco Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state.

Treatment planning, aligner design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, Approver, and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.

The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.

The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of: Attachments, Hooks, Bite ramps, Pontics, Posterior Bite Turbos.

The provided document is a 510(k) summary for the Spark™ Clear Aligner System, seeking substantial equivalence to predicate devices. It primarily focuses on comparing the subject device to existing devices and outlining performance bench testing, rather than describing a study to prove acceptance criteria for an AI device.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The document describes a medical device (Spark™ Clear Aligner System) which includes a "Spark™ Software System" intended for treatment simulation and virtual design of dental casts. However, it does not provide details on specific AI acceptance criteria or a study demonstrating the software's performance against such criteria. The "Non-Clinical Test Data" section mentions "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," and lists several ISO and ASTM standards for biocompatibility, risk management, software life-cycle, usability engineering, and material properties, but does not offer concrete performance metrics or studies in the context of AI.

The document states that "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further confirms that a study to prove AI performance against acceptance criteria, as typically understood in the context of diagnostic or predictive AI, was not performed or reported here.

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This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed.

Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.

The provided document is a 510(k) Pre-Market Notification for the Symetri Clear orthodontic bracket. This type of submission focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than comprehensive clinical performance studies typical for novel medical devices.

Therefore, the document does not contain information about acceptance criteria and the study that proves the device meets those criteria in the context of typical AI/ML device evaluations. Instead, it describes non-clinical performance data to demonstrate equivalence.

Here's an analysis of what is provided, and what is missing based on your requested information:

Key Takeaways from the document:

• Device Type: The Symetri Clear is an orthodontic bracket made from polycrystalline alumina, intended for the orthodontic movement of teeth. It is a physical medical device, not a software/AI device.
• Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to predicate devices (3M Unitek Corporation's Clarity™ ADVANCED Ceramic Brackets (K102803) and Damon™ 4Clear (K081415)).
• Performance Data: The submission relies on non-clinical performance data and biocompatibility assessments to establish substantial equivalence. No clinical performance data was performed or submitted for Symetri Clear.
• No AI/ML Component: There is no indication that the Symetri Clear device itself or its use involves any Artificial Intelligence or Machine Learning component.

Addressing your specific questions based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated as pass/fail numeric thresholds in the document. The general acceptance criterion implied is "perform comparably to the predicate devices" for various non-clinical tests.
   • Reported Device Performance: The document states: "The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices." Specific numerical results for each test (Torque Strength, Double Tie Wing Strength, Bond Strength Shear, Bond Strength Tensile, Wire Drag, Debonding Removal Fracture, Hook Strength, Staining) are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified in this document for the non-clinical tests.
   • Data Provenance: Not specified. It's non-clinical lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. This is a physical device submission demonstrating mechanical and material properties. There is no "ground truth" in the diagnostic sense, nor is there a panel of experts evaluating diagnostic performance. The "ground truth" would be the standard scientific methods and measurements for the physical properties being tested.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. This is not an AI-assisted device. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not Applicable/Implied: For non-clinical tests, the "ground truth" is defined by the standardized measurement methodologies (e.g., ISO 27020 for dimensions) and the results obtained from those methodologies. It's not a diagnostic "ground truth."

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not Applicable. See point 8.

In summary, the provided document is a regulatory submission for a traditional, physical medical device (an orthodontic bracket) and details non-clinical performance testing to demonstrate substantial equivalence to predicate devices, not an AI/ML device with associated acceptance criteria, ground truth, or clinical study designs typically associated with your questions.

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Inspire ICE, a ceramic orthodontic bracket, is intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed.

Inspire ICE, is a single-use orthodontic bracket made from monocrystalline alumina. The brackets are intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. An archwire is then threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Inspire ICE Debonding Pliers. This step is also known as debonding.

This document is a 510(k) premarket notification for the Inspire ICE™ aka Inspire ICE™ Clear Brackets, an orthodontic plastic bracket. The document details the device's characteristics and its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-clinical performance data and the comparison to predicate devices, demonstrating the device performs "as safe, as effective, and performs as well as the predicate devices". Specific quantitative acceptance criteria or pass/fail thresholds for each test are not explicitly stated in this summary. The table below summarizes the reported non-clinical performance data categories.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the non-clinical performance testing (Bond Strength, Tie Wing Strength, Torque Strength, Biocompatibility, Stability testing). It mentions that "internal test methods" were utilized alongside applicable ISO standards.

The data provenance is from non-clinical performance data (laboratory testing) conducted by the manufacturer, Ormco Corporation, or accredited research service companies. The country of origin of the data is not explicitly stated, but the submitter (Ormco Corporation) is based in Orange, California, USA, suggesting the testing was likely conducted in the USA or by labs adhering to international standards (ISO). The testing is prospective for the Inspire ICE device, comparing its performance to already marketed predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes non-clinical performance testing and a comparison to predicate devices for substantial equivalence. It does not involve a "test set" in the context of human interpretation or diagnostic accuracy where expert ground truth would be established by panels of human experts. Instead, the "ground truth" for material properties and mechanical performance would be derived from:

• Established international standards (e.g., ISO 27020, ISO 10993 series).
• Validated laboratory testing methodologies.

Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically understood in studies involving diagnostic accuracy is not directly applicable here. The experts involved would be engineers, material scientists, and toxicologists familiar with the respective ISO standards and testing procedures.

4. Adjudication Method for the Test Set

As this study focuses on non-clinical performance data and comparison to predicate devices, there is no "adjudication method" in the context of resolving discrepancies in expert interpretations (e.g., 2+1, 3+1). The performance is assessed against established technical specifications and international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an orthodontic bracket, a physical medical device, not a software algorithm that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical orthodontic bracket, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission is based on:

• Established performance specifications and standards: Primarily ISO 27020 for orthodontics brackets and tubes, and the ISO 10993 series for biological evaluation of medical devices.
• Validated laboratory testing methodologies: Used to measure Bond Strength, Tie Wing Strength, Torque Strength, Biocompatibility, and Stability.
• Comparison to legally marketed predicate devices: The "ground truth" for demonstrating safety and effectiveness relies on showing that the new device performs equivalently to previously cleared devices which have an established history of safe and effective use.

8. The Sample Size for the Training Set

Not applicable. This device is a physical orthodontic bracket and does not involve AI or machine learning models requiring a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set is involved.

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The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos Digital Impression System (DIS) is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos DIS is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos DIS is a point-of-care turnkey imaging system used in the dental industry; the intra-oral wand hardware and personal computer (PC) based software form an integrated system that produces accurate, high resolution three dimensional (3D) digital images. The end result of an intra-oral patient scan is a 3D digital impression data file that accurately describes the surfaces of teeth, gingiva, and palate within a patient's oral cavity, or the surfaces of a stone model.

The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand along the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic or restorative appliance manufacturers to design and manufacture customized appliances. The Lythos DIS device is also equipped with wireless network capability for secure transfer of the 3D image data to the orthodontic or restorative appliance manufacturer.

The Lythos DIS is only used to gather the topography of the mouth and teeth, and to upload the data file (.stl) to the data cloud. The data is available to the licensed dental professional to send to a third party manufacturer. The Lythos DIS .stl data file is used in conjunction with CAD/CAM or 3D printing manufacturing processes. The proposed Lythos DIS is not used for the design, diagnosis or treatment planning of orthodontic aligners.

Based on the provided text, the Lythos Digital Impression System is an optical impression system for dental professionals. The document is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not necessarily to prove a new device's performance against specific acceptance criteria for AI/ML-based medical devices typically seen today.

Therefore, the information requested in the prompt, particularly related to AI/ML device performance, traditional clinical studies, and specific statistical performance metrics, is largely not present in this regulatory clearance document for a digital impression system. This device is a hardware/software system that captures 3D dental impressions, not an AI/ML algorithm for diagnosis or treatment planning.

However, I can extract information relevant to the device's "performance" in terms of its ability to capture accurate impressions, as well as the types of studies performed to demonstrate its safety and substantial equivalence to a predicate device.

Here's an attempt to answer your questions based only on the provided text, with clarifications where the information is not applicable or not present.

Device Name: Lythos Digital Impression System
Type of Device: Optical Impression System for CAD/CAM in dentistry

Analysis of Acceptance Criteria and Study Proof:

Since this is not an AI/ML device in the modern sense of requiring diagnostic performance metrics (e.g., sensitivity, specificity, AUC), the concept of "acceptance criteria" for an algorithm and "study that proves the device meets the acceptance criteria" as typically understood for AI/ML devices is not directly applicable here.

Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness for its intended use, typically through non-clinical performance data (e.g., accuracy, sterilization, EMC, safety testing).

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the format of a table with numerical targets (e.g., sensitivity > X%, specificity > Y%). Instead, it focuses on demonstrating that the Lythos DIS has "technological characteristics very similar to the predicate device" and that "accuracy testing was performed per internal methods to demonstrate substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states:

• "No human clinical data has been provided to support substantial equivalence."
• Performance data relies on "Non-Clinical Performance Data" and "Internal specification and testing for Lythos Accuracy," "Internal specification and testing for Aligner Accuracy," and "Internal specification and testing to verify use of Surface Enhancement Products."

Therefore, details like sample size for a "test set" in the context of human data (patients/cases), data provenance (country, retrospective/prospective) are not applicable as no human clinical data was used for substantial equivalence. The "test sets" would be non-human elements (e.g., dental models, materials) used for engineering and performance validation. No specific sample sizes for these internal tests are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. Since no human clinical data was used, there were no "experts" establishing ground truth for patient cases as would be required for an AI/ML diagnostic algorithm. Ground truth for accuracy would likely be established by metrology standards for 3D scanning, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. No human clinical test set, so no adjudication method for human readers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an image acquisition system, not an AI assisting human readers. No MRMC study was done, and no human-in-the-loop performance improvement with AI was assessed as there is no stated AI component in the traditional sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in spirit, for the device's functional performance. The "Accuracy testing was performed per internal methods" acts as a standalone performance assessment of the device's ability to accurately capture 3D impressions. However, this is not a diagnostic algorithm's standalone performance in the context of sensitivity/specificity. The output is a data file (.stl), which is then used by a human (dental professional) and other CAD/CAM systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Accuracy testing," the ground truth would typically be established by highly precise metrology equipment or reference objects with known dimensions. The document does not specify the exact methods or reference standards used for this "internal methods" accuracy testing but implies an objective measure of "accuracy."

8. The sample size for the training set

The document does not detail how the internal algorithms for 3D image processing were "trained" in the machine learning sense. The device uses "algorithms in the software process these images into a 3D image." This is likely deterministic image processing / computational geometry, not typical machine learning training. Therefore, not applicable/Not mentioned in the context of ML training data.

9. How the ground truth for the training set was established

Not applicable/Not mentioned. See point 8.

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Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

The provided document describes the Insignia Digicast, a software product and service that creates digital models of patients' teeth for orthodontic diagnostics.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for measurements). Instead, it relies on demonstrating substantial equivalence to predicate devices (OrthoCAD iQ and Lava Digital Models) through qualitative comparisons of features and mode of use, and quantitative comparisons of measurement accuracy.

   Feature/Measurement	Acceptance Criteria (Implied by Substantial Equivalence)	Insignia Digicast Performance (Reported)
   Teeth Width	Functionally equivalent to predicates	Bench tested, successfully validated
   Space	Functionally equivalent to predicates	Bench tested, successfully validated
   T-J Moyers Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Bolton Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Arch Measurements	Functionally equivalent to predicates	Bench tested, successfully validated
   Overbite/Overjet	Functionally equivalent to predicates	Bench tested, successfully validated
   Overall Performance	Substantially equivalent to predicate devices	Deemed substantially equivalent

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in the provided document. The document states "data from bench testing" was used, but does not quantify the number of cases or models tested.
   • Data Provenance: Not explicitly stated. Given it's bench testing, it's likely synthetic data, cadaver models, or a collection of patient impressions, but the origin (e.g., country) is not mentioned. It is a retrospective evaluation against existing (presumably traditional) measurements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not specified. The document indicates that bench testing was used to "evaluate the performance characteristics... compared to the predicate device." It doesn't mention expert involvement in establishing a separate ground truth for the test set beyond the comparisons made with the predicate device's established performance.

4. Adjudication Method for the Test Set:

   • Not specified. This information is typically relevant for human-reader evaluations, which did not occur for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing has not been conducted on this product."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone evaluation was performed. The "Non-Clinical Performance Data" section describes "bench testing" to evaluate the "performance characteristics of Insignia Digicast," which is an algorithm-only assessment. The software was "successfully validated to confirm the performance of the device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the non-clinical performance evaluation was based on comparisons to the predicate device, OrthoCAD iQ, for characteristics such as teeth width, space, and various analyses (T-J Moyers, Bolton, Arch, Overbite/Overjet). This implies the predicate device's measurements served as the reference or accepted standard.

8. The sample size for the training set:

   • Not specified. The document does not provide any details regarding the training data or its size.

9. How the ground truth for the training set was established:

   • Not specified. Since no information on the training set is provided, the method for establishing its ground truth is also unknown.

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Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia with iTero consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.

The provided text describes the "Insignia with iTero" device, an orthodontic treatment planning software and appliance system. It claims substantial equivalence to two predicate devices: "Insignia (K121524)" and "Biomet 3i Using Cadent iTero Scanner (K102209)".

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a typical pass/fail format with specific thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The primary performance aspect highlighted is the accuracy of the digital impression file generated from the iTero scanner.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "Accuracy testing of the digital impression file..." without providing the number of scans or measurements included in this testing.
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not specified. The document simply mentions "Accuracy testing" without detailing how the ground truth for this testing was established or if experts were involved in its determination.

4. Adjudication Method for the Test Set:

• Not specified. There's no mention of any adjudication method (e.g., 2+1, 3+1, none) for the accuracy testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The device is not presented as an AI-assisted diagnostic tool for human readers but rather as a treatment planning software and appliance system. The evaluation focused on the accuracy of the digital impression and substantial equivalence to existing devices, not on human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, implicitly. The "Accuracy testing of the digital impression file generated from the iTero scanner" appears to be a standalone performance evaluation of the scanner component, which produces a digital output (algorithm only) as an alternative to physical impressions. The software then uses this digital model for treatment planning. The "Insignia software" itself also operates in a standalone manner to calculate bracket positions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Not explicitly defined. For the "accuracy testing of the digital impression file," the ground truth likely involved a comparison against a highly accurate reference measurement of the dentition. This could be a physical impression measured with high-precision instruments or a different, highly accurate 3D scanning method considered the gold standard. However, the document does not specify the exact nature of this ground truth.

8. The Sample Size for the Training Set:

• Not applicable/not specified. The document describes a "proprietary software that calculates the position of dental brackets" and the "iTero scanner" which produces digital scans. While these systems likely have internal algorithms that were developed and potentially "trained," the document does not discuss a training set in the context of machine learning or AI models in the modern sense. The focus is on the output accuracy of the system's components.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/not specified. As with the training set itself, the document does not provide details on how ground truth would have been established for any internal training or development of the software or scanner's algorithms.

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The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.

The provided document (K122065 510(k) Summary) describes the Digital Impression System for Orthodontic Use (DIS) and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding numerical performance metrics for the device. Instead, the "acceptance criteria" are implied by the non-clinical test's conclusion of "substantial equivalence" to traditional methods (PVS impressions).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for the "3D topographical files" comparison study. It only states that "files were created" and "compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the comparison study. The ground truth appears to be based on "digitized polyvinylsiloxane (PVS) traditional impressions," which themselves are physical impressions. How the "ground truth" was established from these PVS impressions (e.g., by expert measurement, specific metrology tools) is not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing has not been conducted on this product." The comparison was between digital files from the DIS and digitized traditional impressions, not involving human readers comparing output from the DIS versus traditional methods.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary test described is a standalone performance assessment. The comparison was between the 3D topographical files generated solely by the Digital Impression System for Orthodontic Use (algorithm + hardware) and files derived from digitized traditional impressions. There is no mention of human interaction or interpretation as part of this comparison.

7. The Type of Ground Truth Used

The ground truth used was based on "digitized polyvinylsiloxane (PVS) traditional impressions." This implies that the PVS impressions served as the reference for accurate topographical representation of teeth, gingiva, and/or palate. It is a form of empirical ground truth based on an established, existing clinical method.

8. The Sample Size for the Training Set

The document does not mention a training set nor its sample size. This suggests the comparison was likely an evaluation of a fully developed system rather than an iterative model training and validation process often associated with machine learning.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not applicable/not provided.

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